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NCT03873987 · ClinicalTrials.gov registry record · Phase 1
Relative Exposure and Safety Study of Kimyrsa in ABSSSI Patients
A Phase 1 study, sponsored by Melinta Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 102
- Enrollment target
NCT03873987: Completed Phase 1 study, sponsored by Melinta Therapeutics.
NCT03873987 is a Phase 1 study that has completed, run by Melinta Therapeutics. The registered enrollment target is 102 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03873987, a Phase 1 study, has completed, sponsored by Melinta Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 102 participants
- Enrollment target
Study Summary
This study is being conducted to evaluate the pharmacokinetic (PK) and safety of Kimyrsa versus the approved oritavancin formulation in subjects with acute bacterial skin and skin structure infection (ABSSSI). Kimyrsa adjusts the infusion time, concentration and reconstitution/administration solutions of a single 1200 mg intravenous (IV) infusion of oritavancin
Primary Outcome
Relative exposure of AUC of the new formulation to the approved formulation of oritavancin based on area under the plasma concentration-time curve from time zero to 72 hr (AUC0-72)
Interventions
- DRUG Kimyrsa
- DRUG Current Formulation of Oritavancin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2019-07-16 |
| Est. Completion | 2019-09-04 |
| Phase | Phase 1 |
What the finished NCT03873987 record still lists
NCT03873987 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% higher).
The record links to 0 conditions, and to 2 interventions - of which Kimyrsa is the first listed.
NCT03873987 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03873987 about?
NCT03873987 is a clinical study titled "Relative Exposure and Safety Study of Kimyrsa in ABSSSI Patients". This study is being conducted to evaluate the pharmacokinetic (PK) and safety of Kimyrsa versus the approved oritavancin formulation in subjects with acute bacterial skin and skin structure infection (ABSSSI). Kimyrsa adjusts the infusion time, concentration and reconstitution/administration solutio...
What is the current status of trial NCT03873987?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 102 participants. The study started on 2019-07-16. Estimated completion is 2019-09-04.
What interventions are being tested in trial NCT03873987?
The interventions under investigation include: Kimyrsa (DRUG), Current Formulation of Oritavancin (DRUG).
Who is sponsoring clinical trial NCT03873987?
This trial is sponsored by Melinta Therapeutics, which has 31 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03873987's enrollment target sits among peer trials
102 543rd of 2000 higher than 1,455 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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